Trial | NCT02115204  Report issue

Title

4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF
Adjuvant Chemotherapy of Breast Cancer: Sequential Chemotherapy vs. Standard Therapy. Prospective Randomised Comparison of 4 x Epirubicin and Cyclophosphamide (EC) --> 4 x Docetaxel (Doc) vs. 6 x CMF / CEF in Patients With 1 to 3 Positive Lymph Nodes

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2011
Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German Study Group and "Arbeitsgemeinschaft Gynäkologische Onkologie" (WSG-AGO) EC-Doc is a large trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3 involved lymph nodes (LN).
Study Started
Jun 30
2000
Primary Completion
Aug 31
2005
Study Completion
Aug 31
2010
Last Update
Oct 03
2019

Drug Docetaxel

Drug Epirubicin

Drug Cyclophosphamide

Drug Methotrexate

Drug 5-fluorouracil

EC-Doc Experimental

4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks

CMF/CEF Active Comparator

6 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) (600/40/600) i.v., day 1 + 8, q = 4 weeks or 6 cycles cyclophosphamide, epirubicin, 5-fluorouracil (CEF) (500/100/500) i.v., day 1, q = 3 weeks

Criteria 

Inclusion Criteria:

Female patients
Age 18-65 years
Eastern Cooperative Oncology Group (ECOG) status < 2
Surgery: R0-resection and >= 10 removed axillary lymph nodes
M0 by chest x-ray, bone scintigraphy and liver sonography

Exclusion Criteria:

Polyneuropathy
Creatinin (serum) > 1,4 mg/dl; Bilirubin (serum) > 2,0 mg/dl
Cardia dysfunction, ejection fraction < lower normal value of each institution
Hematopoeitic insufficiency: leucocytes < 3,5 G/l, thrombocytes < 100 G/l
second malignant neoplasia, except curatively treated basalioma of the skin
Surgery before more the six weeks (42 days)
Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
Breast feeding woman
Sequential breast cancer
Reasons indicating risk of poor compliance
Patients not able to consent
No Results Posted